Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-25 @ 1:59 PM
NCT ID:
NCT01900392
Description:
None
Frequency Threshold:
0
Time Frame:
1 year
Study:
NCT01900392
Study Brief:
Financial Incentives for Maintenance of Weight Loss
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Lottery | In addition to the incentives for the 3-, 6-, 9-, \& 12-month weigh-ins, participants who meet their daily goal will be eligible for the daily lottery during the first 6 months of the study. The expected daily winning for the lottery is the same as for the direct payment arm. All daily incentive earnings will be paid out after verifying participants' weights during an in person weigh in at a Weight Watchers location at months 3 and 6. Winnings will be proportional to weight loss. For example, if a participant's goal was to lose 6 pounds by month 3, but he/she only lost 3 pounds, that participant would only receive 50% of their total eligible winnings. Similar to the control arm, participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weigh-ins at 9- and 12-months will also be required. | 0 | None | 2 | 77 | 2 | 77 | View |
| Direct Payment | In addition to the incentives for the 3-, 6-, 9-, \& 12-month weigh-ins, participants who meet their daily goal will be eligible to receive an incentive for each day their goal is met during the first 6 months of the study. All daily incentive earnings will be paid out after verifying participants' weights during an in person weigh in at a Weight Watchers location at months 3 and 6. Winnings will be proportional to weight loss. For example, if a participant's goal was to lose 6 pounds by month 3, but he/she only lost 3 pounds, that participant would only receive 50% of their total eligible winnings. Similar to the control arm, participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weigh-ins at 9- and 12-months will also be required. | 1 | None | 9 | 75 | 1 | 75 | View |
| Control | No other financial incentive other than for the 3-, 6-, 9-, \& 12-month weigh-ins and surveys. Participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). Two weigh-ins will be required during Phase II, one at 9 months and the other at 12 months. | 0 | None | 4 | 39 | 1 | 39 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hysterectomy | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Hip replacement | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Concussion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Brain aneurysm | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Ruptured appendix | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Temporal artery biopsy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Lymphoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Angina | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Breast cancer | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Vascular surgery | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ganglion cyst outpatient surgery | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Sciatica from car accident | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Broken foot | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Torn ACL and MCL, broken ankle | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |